To assess the effect of intravenous paracetamol on reduction of hourly average consumption of epidural levobupivacaine and fentanyl mixture in labouring parturients

Intravenous paracetamol as an adjunct to patient-controlled epidural analgesia with levobupivacaine and fentanyl in labour: a randomized controlled study

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2013/09/003968

Enrollment

Registered

2013-09-11

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Pregnant Parturient

Interventions

Intervention1: epidural technique for labour analgesia using levobupivacaine and fentanylusing PCEA pump: role of intravenous paracetamol in reducing consumption of levobupivacaine and fentanyl mixtur

Eligibility

Inclusion criteria

Inclusion criteria: • American Society of Anesthesiologists (ASA) grade I and II • Age >18 years • Primigravida • Single gestation • Cephalic presentation at >= 36 wk of gestation • In early spontaneous labour (cervical dilation • Baseline pain score > 30 (on a 0-100 VAS) • Able to use PCEA pump • Requesting epidural analgesia for labour

Exclusion criteria

Exclusion criteria: • Refusal by parturient • Parturients who had received parenteral opioids in the last 4 hours • Systemic and local sepsis • Deranged coagulation profile • Parturients having multiple pregnancies and premature labour • Obstetric complications (e.g., premature rupture of amniotic membranes) • Noncephalic presentations • Allergy to study drugs, i.e., paracetamol, levobupivacaine and fentanyl

Design outcomes

Primary

Measure	Time frame
Hourly average consumption of levobupivacaine and fentanyl mixture, including both continuous background infusion plus bolus doses (in ml)Timepoint: starting from 1 hour after administration of paracetamol or saline, till delivery.	—

Secondary

Measure	Time frame
Maternal satisfaction (VAS) Pain score (VAS) Sensory and motor block characteristics Haemodynamic parameters of mother Foetal heart rate Duration of second stage of labour Mode of delivery Apgar scores Adverse effects Timepoint: starting from 1 hour after administration of paracetamol or saline, till delivery.	—

Countries

India

Contacts

Public ContactProf Sukanya Mitra

Government medical college and hospital

drsmitra12@yahoo.com9646121521

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026